NCT01657162

Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,139 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Detailed description

To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Alendronate	Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.

Timeline

• Start date: 2012-11-20
• Primary completion: 2016-10-03
• Completion: 2016-10-03
• First posted: 2012-08-06
• Last updated: 2020-12-11
• Results posted: 2020-12-11

Locations

25 sites across 10 countries: United States, Argentina, Brazil, Czechia, Denmark, Estonia, Hong Kong, Lithuania, Poland, Romania

Regulatory

• FDA-regulated drug study